Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer

Abstract

Objective: To assess the impact of Guide to Decide (GtD), a web-based, personally-tailored decision aid designed to inform women's decisions about prophylactic tamoxifen and raloxifene use.

Methods: Postmenopausal women, age 46-74, with BCRAT 5-year risk ≥ 1.66% and no prior history of breast cancer were randomized to one of three study arms:intervention (n=690), Time 1 control (n=160), or 3-month control (n=162). Intervention participants viewed GtD prior to completing a post-test and 3 month follow-up assessment. Controls did not. We assessed the impact of GtD on women's decisional conflict levels and treatment decision behavior at post-test and at 3 months, respectively.

Results: Intervention participants had significantly lower decisional conflict levels at post-test (p<0.001) and significantly higher odds of making a decision about whether or not to take prophylactic tamoxifen or raloxifene at 3-month follow-up (p<0.001) compared to control participants.

Conclusion: GtD lowered decisional conflict and helped women at high risk of breast cancer decide whether to take prophylactic tamoxifen or raloxifene to reduce their cancer risk.

Practice implications: Web-based, tailored decision aids should be used more routinely to facilitate informed medical decisions, reduce patients' decisional conflict, and empower patients to choose the treatment strategy that best reflects their own values.

Trial registration: ClinicalTrials.gov NCT00967824.

Conflict of interest statement

Competing interests

None declared.

Published by Elsevier Ireland Ltd.

Figures

Fig. 1

Guide to Decide consort diagram.

Fig. 2

Participants’ stage of decision making at 3-month follow-up. Notes: Percentages based on those participants who reported to have not made a decision about whether or not to take a chemoprevention drug at 3-month follow up (intervention group n = 171, Time 1 control n = 67, and 3-month control n = 70).

Fig. 3

Stage of decision making and preparation for decision making among intervention group participants in the decision making process. Notes: The F-statistic is based on the F-test for trend. Estimated values are the mean preparation for decision making (PrepDM) score, at post-test, among intervention group participants in each stage of the decision making process, who had not made a decision about whether or not to take a breast cancer chemoprevention drug at 3-month follow-up survey. All responses are based on intervention group participants with a valid (non-missing) post-test PrepDM score (n = 169).